Long nose manipulatable catheter

ABSTRACT

The long nose manipulatable catheter includes a main lumen, a wire lumen with a push-pull wire therethrough, and a flexible joint region. The catheter section includes a control including a handle and a wire control member engaging the push-pull wire for manipulating the flexible joint region. The push-pull wire may be tapered, having a proximal portion of a first diameter and a smaller diameter distal portion. A coil may be placed around the smaller diameter to prevent buckling of the smaller diameter portion. A strapping coil may also disposed around the outside of the catheter, and an outer covering may be disposed around the strapping coil. An outer covering of a mesh may also be disposed around the distal tip of the catheter.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part application of Ser. No.10/678,008, filed Oct. 1, 2003 now U.S.Pat.No. 7,591,813, which isincorporated herein by reference in its entirety and to whichapplication we claim priority under 35 U.S.C. §120.

FIELD OF THE INVENTION

The invention is generally in the field of intravascular devices. Moreparticularly, it relates to intravascular catheters having a flexibleand manipulatable hinge or joint region. The delivery lumen may be alsoused for placement of occlusive materials, e.g., in an aneurysm.

BACKGROUND OF THE INVENTION

Endovascular therapy has been used to treat different conditions, suchtreatments including control of internal bleeding, occlusion of bloodsupply to tumors, and occlusion of aneurysm. Often the target site ofthe malady is difficult to reach. Because of their ability to accessremote regions of the human body and deliver diagnostic or therapeuticagents, catheters are increasingly becoming components of endovasculartherapies. Generally, catheters are introduced into large arteries, suchas those in the groin or in the neck, and then pass through narrowingregions of the arterial system until the catheter's distal tip reachesthe selected delivery site. To be properly utilized, catheters are oftenstiffer at their proximal end to allow the pushing and manipulation ofthe catheter as it progresses through the body but sufficiently flexibleat the distal end to allow passage of the catheter tip through thebody's blood vessels without causing significant trauma to the vessel orsurrounding tissue.

Microcatheters, such as those shown in U.S. Pat. Nos. 4,884,579 and4,739,768, each to Engleson, allow navigation through the body'stortuous vasculature to access such remote sites as the liver or thecerebral arteries of the brain. Although other methods of causing acatheter to proceed through the human vasculature exist (e.g., flowdirected catheters), a guidewire-aided catheter is considered to be bothquicker and more accurate than other procedures. Catheters withdeflectable or variable stiffness distal ends (which increase theflexibility of the catheter's distal end) have been disclosed in U.S.Pat. No. 6,083,222, to Klein et al; U.S. Pat. No. 4,983,169, toFurukawa; U.S. Pat. No. 5,499,973, to Saab; and U.S. Pat. No. 5,911,715,to Berg et al.

The addition of a fluid-expandable balloon on the distal end of thecatheter and a coupler on the proximal end allows various percutaneousmedical treatments such as pressure monitoring, cardiac output and flowmonitoring, angioplasty, artificial vaso-occlusion, and cardiac support.Balloon catheters generally include a lumen that extends from theproximal end and provides fluid to the balloon for inflation. Examplesof balloon catheters are disclosed in U.S. Pat. No. 4,813,934 toEngleson et al and U.S. Pat. No. 5,437,632 to Engelson et al. A ballooncatheter with an adjustable shaft is shown in U.S. Pat. No. 5,968,012,to Ren et al.

For certain vascular malformations and aneurysms, it may be desirable tocreate an endovascular occlusion at the treatment site. A catheter istypically used to place a vaso-occlusive device or agent within thevasculature of the body either to block the flow of blood through avessel by forming an embolus or to form such an embolus within ananeurysm stemming from the vessel. Formation of an embolus may alsoinvolve the injection of a fluid embolic agent such as microfibrillarcollagen, Silastic beads, or polymeric resins such as cyanoacrylate.Ideally, the embolizing agent adapts itself to the irregular shape ofthe internal walls of the malformation or aneurysm. Inadvertent embolismdue to an inability to contain the fluid agent within the aneurysm isone risk which might occur when using fluid embolic agents.

Mechanical vaso-occlusive devices may also be used for embolusformation. A commonly used vaso-occlusive device is a wire coil or braidwhich may be introduced through a delivery catheter in a stretchedlinear form and which assumes an irregular shape upon discharge of thedevice from the end of the catheter to fill an open space such as ananeurysm. U.S. Pat. No. 4,994,069, to Ritchart et al, discloses aflexible, preferably coiled, wire for use in a small vesselvaso-occlusion. Some embolic coils are subject to the same placementrisks as that of fluid embolic agents in that it is difficult to containthe occlusive coil within the open space of the aneurysm.

Another example of a steerable catheter is disclosed in U.S. Pat. No.4,723,936, to Buchbinder et al. Buchbinder describes a steerablecatheter having a spring coil body defining a lumen and a deflectionwire extending through the catheter. The deflection wire is positionedeither inside or outside the spring coil body but is not containedwithin a separate wire lumen.

U.S. Pat. No. 4,960,411, also to Buchbinder, discloses a steerablecatheter device having a deflection wire within a separate wire lumen.The distal end of the wire lumen is a closed end and has the distal endof the deflection wire embedded therein.

U.S. Pat. No. 6,251,092, to Qin et al., discloses a deflectable guidingcatheter similarly having a deflection wire or member contained within alumen. The distal end of the wire lumen is similarly closed and has thedistal end of the deflection member embedded therein.

U.S. Pat. No. 6,321,749, to Toti et al., discloses an endotracheal tubewhich is manipulatable via a tensioning wire within a lumen. The wire isexposed within an open area of the tube and is used in conjunction witha variety of biased deflection members to assist in manipulating thetube.

However, none of the above-mentioned devices discloses an intravasculardevice having a small diameter, highly flexible construction whichpermits movement along a small-diameter, tortuous vessel path, andhaving a flexible method of placement to ensure accuracy, as disclosedherein.

It has also been found that in a catheter assembly including a catheterbody including a push-pull wire attached to a distal flexible jointregion and passing through a wire lumen extending through the catheterbody, that pushing of the push-pull wire can cause a narrowed, moreflexible distal tip portion of the push-pull wire to buckle and rupturethe wire lumen and catheter body. It would therefore be desirable toprovide such a catheter assembly with a reinforcement of the flexibledistal tip portion of the push-pull wire to provide for distribution ofstress over the flexible distal tip portion of the push-pull wire toprevent buckling of the push-pull wire. It would also be desirable toprovide such a catheter assembly with a reinforcement of the distal tipportion of the catheter body to prevent rupture of the lumen, andreinforce flexible distal tip portion of the push-pull wire. The presentinvention addresses these and other needs.

SUMMARY OF THE INVENTION

A catheter or catheter section described below may be utilized fornegotiating movement along small-diameter, tortuous vessels. Thecatheter may comprise a flexible joint region which defines a main lumenand an adjacent wire lumen therethrough, the wire lumen having anopening near or at a distal end of the flexible joint region; apush-pull wire configured to be pushed or pulled along a longitudinalaxis of the wire through the wire lumen; and wherein the flexible jointregion has a predetermined length sized to affect a flexure of theflexible joint region. Moreover, the catheter assembly may furthercomprise at least one radio-opaque marker band near or at the distal endof the flexible joint region for securing the push-pull wire thereto,wherein the flexible joint region has a predetermined length sized toaffect a flexure of the flexible joint region.

An inflatable balloon member may optionally be used with the catheterassembly. If the inflatable member is utilized, the flexible joint mayvariously be distal of the inflatable member, within the inflatablemember, or proximal of said inflatable member.

One particular variation of the catheter assembly may have a catheterbody which defines a main lumen through the length of the assembly. Apush-pull wire lumen having an open distal end may also be definedthrough the length of the catheter body, or at least through a majorityof the length of catheter body, extending from a fitting at a proximalend of the catheter assembly to a region near or at the distal end ofthe device. The catheter body itself may be comprised of several regionseach having a different degree of flexibility. For instance, thecatheter assembly may comprise a first portion distal of the fittinghaving a first stiffness. A second portion, having a second stiffnessand located distal of the first portion, may be more flexible relativeto the first portion. Likewise, a third portion, having a thirdstiffness and located distal of the second portion, may be more flexiblerelative to the first and second portions. Thus, the catheter body mayhave a length comprised of progressively more flexible sections thefarther distally located along the catheter. Distal to the thirdsection, bending portion or flexible joint region may be positioned, asdescribed in further detail below.

The push-pull wire lumen may include a braided ribbon integratedthroughout the length of the lumen. Alternatively, the braided ribbonmay be integrated through the lumen to terminate proximally of the jointregion. The braided ribbon may be a uniform braid or it may be braidedwith a varying braid pitch. The braided ribbon may be made from a numberof materials. For instance, metals which are members of a class ofalloys known as super-elastic alloys may be utilized for the braidmaterial.

The manipulatable or flexible joint region is generally located at thedistal end of the catheter body and is configured to bend whenmanipulated by the push-pull wire. The bending portion itself may bevaried to extend to where the braid terminates, or it may be extended tothe bending portion to encompass a portion of the braid. By varying thelength of the flexible joint region, the amount of curvature and flexureof the joint region can be controlled. For instance, a joint regionhaving a relatively shortened length between the distal end of the jointregion and the terminal end of the braid may allow for a reduced degreeof flexure relative to a neutral position of the catheter. Incomparison, a lengthened joint region extending to a more proximallylocated terminal end may allow for a relatively greater degree offlexure. Accordingly, the degree of flexure may be controlled in part bythe length of the flexible joint region. Thus, the flexible region maybe flexed up to 90° relative to the longitudinal axis of the catheterassembly and in some cases, the flexible region may be flexed up to 180°relative to the longitudinal axis depending upon the length of theflexible joint region. To further facilitate bending of the catheter,additional members such as coils may be incorporated into the device,for instance in the transitional region, to aid in further controllingthe bending of the joint region.

In another presently preferred aspect, the catheter section of thepresent invention includes a tubing extension extending distally fromthe main lumen of the distal end of the flexible joint region. In apresently preferred aspect, the radio-opaque marker band may be attachedto the tubing extension. The push-pull wire typically extends throughthe opening of the wire lumen at the distal end of the flexible jointregion, and may be attached to the marker band attached to the tubingextension.

In another presently preferred aspect, the catheter section of thepresent invention includes a control in communication with a proximalend of the push-pull wire for manipulating the flexible joint region.The control typically includes a handle receiving the proximal end ofthe push-pull wire; and a wire control member mounted to the handle andengaging the push-pull wire, whereby movement of the wire control membertranslates the push-pull wire along the longitudinal axis of thepush-pull wire. In one presently preferred aspect, the handle includes apush-pull wire guide extending from the handle, and the push-pull wirepasses through the push-pull wire guide for transitioning the push-pullwire to the catheter body. In another presently preferred aspect, thehandle is integrated into a catheter fitting connected to the catheterbody, the catheter fitting including a main lumen access and a push-pullwire access.

In one currently preferred embodiment of the control, the proximal endof the push-pull wire is attached to a rack bearing a plurality ofengagement teeth, and the wire control member engaging the engagementteeth of the rack, whereby movement of the wire control member advancesthe rack proximally or distally to thereby translate the attachedpush-pull wire along the longitudinal axis of the push-pull wire. In apresently preferred embodiment, the wire control member includes a wheeldefining a concentrically configured gear engaging the engagement teethof the rack, whereby rotation of the wheel advances the rack proximallyor distally to thereby translate the push-pull wire along thelongitudinal axis of the push-pull wire.

In another presently preferred embodiment, the proximal end of thepush-pull wire is attached to a wire carriage, and the wire controlmember includes a carriage screw disposed within the handle, the wirecarriage being configured to travel within an advancement channeldefined within the handle, and a proximal end of the carriage screwbeing attached to a control knob that may be rotated to advance the wirecarriage and the push-pull wire either proximally or distally along thelongitudinal axis of the push-pull wire.

In another presently preferred embodiment, the proximal end of thepush-pull wire is attached to a wire carriage, and the handle comprisesa control release knob attached to a release screw attached to the wirecarriage, whereby the control release knob may be translated proximallyor distally such that the wire carriage travels within an advancementchannel to advance or retract the push-pull wire. In a presentlypreferred aspect, the control release knob may be tightened about therelease screw against the handle to lock a position of the push-pullwire.

In another presently preferred embodiment, the proximal end of thepush-pull wire is attached to a wire carriage, and wherein the wirecontrol member comprises a control slide configured to proximally ordistally advance the wire carriage within the handle to therebytranslate the push-pull wire along the longitudinal axis of thepush-pull wire.

In another presently preferred embodiment, the present inventionprovides for a catheter section including a catheter body having aproximal end and a distal end, the catheter body including a distalflexible joint region, a main lumen extending through the catheter bodyand through the flexible joint region, and a wire lumen adjacent to themain lumen and extending through the catheter body and through theflexible joint region. The wire lumen of the flexible joint region hasan opening near or at a distal end of the flexible joint region, and atapered push-pull wire is provided, having a proximal portion of a firstdiameter and a distal portion of a smaller diameter than the firstdiameter. The push-pull wire is configured to be pushed or pulled alonga longitudinal axis of the wire through the wire lumen, and the distalend of the push-pull wire is attached to the distal flexible jointregion. In a presently preferred embodiment, a coating of a materialwith a low coefficient of friction is disposed over the push-pull wire.

A coil is also preferably disposed around the smaller diameter distalportion of the push-pull wire, which has the effect of distributingstress along the smaller diameter portion of the push-pull wire toprevent buckling of the smaller diameter portion of the push-pull wire,so that the tip of the push-pull wire does not deflect and rupture thecatheter body. A control is also provided in communication with aproximal end of the push-pull wire for manipulating the flexible jointregion.

In another presently preferred embodiment, a strapping coil is disposedaround the outside of the catheter, and an outer covering formed of apolymeric material, such as PEBAX, for example, may be disposed aroundthe strapping coil. In another variation, an outer covering of a meshformed of a polymeric material, such as polyethylene terephthalate, forexample, may be disposed around the distal tip of the catheter. Inanother presently preferred aspect, at least one radio-opaque band maybe mounted to the catheter body near or at the distal end of theflexible joint region, the push-pull wire extends through the opening ofthe wire lumen at the distal end of the flexible joint region, andpush-pull wire is attached to the marker band. In another presentlypreferred aspect, the wire lumen further comprises a braid along atleast a substantial portion of the wire lumen, and typically the braidterminates proximally of the flexible joint region. In another presentlypreferred aspect, the main lumen includes a lining, such as a lubriciouslining, for example, along at least a substantial portion of the mainlumen. The wire lumen may also be provided with a lining, such as alubricious lining, for example, along at least a substantial portion ofthe wire lumen.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIG. 1A shows an external view of one variation of the catheterassembly.

FIGS. 1B and 1C show alternative configurations of the distal region ofthe catheter assembly.

FIG. 2A shows a cross sectional view of a proximally placed hinge regionin a variation of the distal region of the catheter assembly.

FIG. 2B shows a cross sectional view of a mid-balloon hinge regionplacement for another variation of the distal region of the catheterassembly.

FIG. 2C shows a cross sectional view of a distally placed hinge regionin another variation of the distal region of the catheter assembly.

FIG. 2D shows a cross sectional view of an additional mid-balloon hingeregion placement for another variation of the distal region of thecatheter assembly.

FIGS. 3A-3H are cross-sectional views of catheter shafts displaying thevarious relative positions of the push-pull wire lumen, main lumen, andoptional inflation lumen.

FIG. 4A shows a cross-sectional side view of another variation of acatheter assembly.

FIG. 4B shows a detail side view in which a portion of the tubingdefining the main lumen extends as an extension past a distal face ofthe joint region.

FIG. 4C shows end view of flexible joint region of FIG. 4B.

FIG. 4D shows a cross-sectional end view of the catheter bodyillustrating the wire lumen and the main lumen.

FIG. 5A shows an assembly side view of the distal portion of a variationof the catheter assembly.

FIGS. 5B and 5C show bending of the flexible joint regions of cathetershaving differing lengths of the flexible joint regions.

FIGS. 6A and 6B show cross-sectional side and detail side views,respectively, of another variation of the device where the distal endmay be fused down by a liner.

FIGS. 7A to 7C show side, end, and partially removed side views,respectively, of one variation of a control handle for manipulating thepush-pull wire.

FIGS. 7D and 7E show detail views of the wheel and rack, respectively,which may be used to manipulate the push-pull wire.

FIG. 8 shows another variation in the cross-sectional side view ofcombination fitting/handle assembly.

FIG. 9 shows another variation in the cross-sectional side view of thehandle body utilizing a carriage screw.

FIG. 10 shows another variation in the cross-sectional side view of thehandle body utilizing a control/release knob.

FIG. 11 shows another variation in the cross-sectional side view of thehandle body utilizing a control slide.

FIG. 12 is a cross-sectional view of another variation of the distalregion of the catheter assembly including a coil over a distal portionof the push-pull wire.

FIG. 13 is a perspective diagrammatic view illustrating the variation ofFIG. 12.

FIG. 14 is a cross-sectional view of another variation of the distalregion of the catheter assembly including a strapping coil over a distalportion of the catheter body.

FIG. 15 is a cross-sectional view of another variation of the distalregion of the catheter assembly including a mesh over a distal portionof the catheter body.

FIG. 16 is a perspective diagrammatic view illustrating the variation ofFIG. 15.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

This invention involves a multi-lumen catheter for the delivery ofvaso-occlusive materials or implants. The device may optionally includea balloon member. The device is shown in detail in the figures whereinlike numerals indicate like elements. The catheter preferably includes ashapeable, flexible distal section which may be in the vicinity of theballoon, if the balloon member is utilized. The flexible section, or“hinge region”, preferably is manipulated from outside the body duringthe process of delivering the vaso-occlusive device or material. Theterms “hinge region”, “hinge”, or “flexible joint” may be usedinterchangeably.

FIG. 1A shows a catheter assembly 23 made according to one variation ofthe invention. This variation of the catheter assembly 23 includes acatheter shaft 25 composed of a flexible, thin walled body or tube 26having an inner lumen which extends between proximal and distal catheterends 24, 37, respectively. The tube 26 is preferably a generallynondistensible polymer having the appropriate mechanical properties forthis application, and preferably polyethylene (e.g., HDPE, LDPE, LLDPE,MDPE, etc.), polyesters (such as Nylon), polypropylene, polyimide,polyvinyl chloride, ethylvinylacetate, polyethylene terephthalate (PET),polyurethane (e.g., TEXIN such as that made by Bayer Corporation),PEBAX, fluoropolymers, such as polytetrafluoroethylene (PTFE), forexample, mixtures of the aforementioned polymers, and their block orrandom co-polymers.

The catheter assembly may be utilized for access through the vasculatureto the brain often, but not necessarily, using a guide wire. If anoptional balloon member is included in the catheter assembly, theballoon member may be inflated to close or to restrict any hollow bodylumen, such as an artery, vein, orifice, cavity, etc., or the mouth ofan aneurysm prior to or during placement of a vaso-occlusive device.Generally, the assembly may be flexed at a “hinge region” near or at thedistal end of the catheter by a push-pull wire extending proximallythrough the catheter. A main lumen defined through the catheter assemblymay be utilized for the introduction of a vaso-occlusive device ormaterial for eventual placement in the vasculature.

The proximal catheter end 24 may be provided with a fitting 18 (e.g., a“LuerLok”) through which fluid may be supplied to the catheter'sinflation lumen through a side port 16. The proximal end of the catheteris provided with a second port 20 and a fitting 22 through which thepush-pull wire may be used to manipulate the hinge region 32 in thedistal catheter tip. The proximal end fitting 18 includes an axiallyextending port 14 which communicates with the catheter's delivery/guidewire lumen. The optional guide wire 12 may have any suitableconstruction for guiding the flexible catheter to its intended sitewithin the body. The proximal end of the guidewire 12 may be equippedwith a handle 10 for applying torque to the guidewire 12 during catheteroperation, as described in further detail below. The guidewire may havea variable stiffness or stepped diameter along its length whichtypically, e.g., a larger-diameter, stiffer proximal region and one ormore smaller-diameter, more flexible distal regions.

The distal portion 35 of the catheter may include an optional inflatablemember 30, typically a balloon. An opening 36 at the distal end of thecatheter may also be used for delivery of drugs and/or vaso-occlusivedevices to a pre-selected vascular site. The distal end region 35 of thecatheter 25 may be provided with an inflatable balloon 30 which, wheninflated, may aid in the placement of vaso-occlusive materials ordevices by blocking the entrance to the aneurysm or the artery adjacentto the aneurysm. An example of a catheter assembly which incorporates aballoon member with a flexible joint is disclosed in further detail inU.S. patent application Ser. No. 09/643,085 filed Aug. 21, 2000, whichis co-owned and incorporated herein by reference in its entirety.

Although a balloon member is illustrated in several variations, use ofthe balloon member is merely optional. The balloon wall section(discussed in greater detail below) is preferably formed from a thinsleeve of polymeric material and attached at its opposite sleeve ends toa relatively more rigid tube section. FIGS. 1A, 1B, and 1C displayvarious configurations of the distal catheter tip 35 positioning basedon the placement of the flexible hinge region. FIGS. 1A, 1B, and 1C,respectively, show variations of the inventive catheter 23 in which thehinge region 32 is placed proximal to (FIG. 1A), within (FIG. 1B), anddistal to (FIG. 1C) the inflatable member region 30 if such aninflatable member 30 were included in the catheter assembly. Flexion ofthe hinge region may be achieved through remote manipulation of thepush-pull wire 21.

FIGS. 2A through 2D illustrate variations of the distal end region 35and hinge region 32 of the catheter illustrated in FIGS. 1A, 1B, and 1C.The catheter tube 40 of FIG. 2A may have an inflatable member 44, e.g.,a balloon, formed by an inflatable sleeve secured at its ends 41, 43 tothe catheter tube wall 40. The inflatable member or balloon 44 may be ofa shape, thickness, and material as is typical of balloons used inneurovascular balloon catheters. Preferably, though, the inflatablemember or balloon 44 may be formed of a thin polymeric material, andpreferably an elastomeric, stretchable material such as silicone rubber,latex rubber, polyvinyl chloride, complex co-polymers such asstyrene-ethylene butylene-styrene copolymers such as C-FLEX, oralternatively, a non-stretchable film material such as polyethylene,polypropylene, or polyamides such as Nylon. Attachment of the sleeveends to the catheter tube may be by adhesives, heat shrinkage,mechanical fasteners, or other suitable method. Inflation lumen 42,which is also optional if balloon 44 is included in the assembly, allowscommunication between the inflation fluid source and the balloon 44through at least one opening 50 formed in the catheter tube 40.Inflation and deflation of the balloon are effected by the passage ofradio-opaque fluid, saline, or other fluid. A push-pull wire lumen 60may extend throughout the catheter tube 40 to protect the passage of thepush-pull wire 62. To assist in preventing collapse of the tube 60enclosing the push-pull wire 62 and to prevent kinking or bulging duringactuation, the push-pull wire lumen 60 may have additional structurepreferably provided by a layer of higher stiffness polymer (e.g., apolyimide), a support coil, or a support braid, as described in furtherdetail below.

Manipulation of the push-pull wire 62 via the proximal wire port 20 inFIG. 1A may result in flexion of the distal end 35 of the catheter 25.The guidewire 57 may extend through the delivery lumen 55 which liesinterior to the catheter tube 40. The push-pull wire 62 may extendthrough the push-pull wire lumen 60 and may be attached to radio-opaqueband 67, which may surround the catheter distal end 65 and may be madeof a variety of radio-opaque material such as stainless steel, platinum,gold, nickel, etc. The hinge region 58 at which the distal catheter tip65 flexes due to proximal manipulation of the push-pull wire 62 may belocated proximal to, within, or distal to the balloon (if used), asdisplayed respectively in FIGS. 2A, 2B, and 2C. Although the inclusionof a balloon with the catheter assembly is described herein, the balloonis optional and may be omitted entirely from the catheter assembly.

As shown in FIG. 2A, when the hinge region 58 is placed proximally ofthe balloon 44, the push-pull wire lumen 60 extends to a region which isproximal of the distal end of the balloon 44 to allow flexion of theregion of the catheter's distal end 65 which includes the entire balloon44. If the hinge region 58 is placed interior to the balloon, as in FIG.2B, flexion of the catheter's distal end 65 occurs such that the pointof flexion is within the balloon (also displayed in FIG. 1B). FIG. 2Cshows the placement of hinge 58 distal to the balloon; flexion duringdistal-hinge placement occurs such that the manipulatable region of thecatheter's distal end 65 does not include any portion of the balloon 44.

FIG. 2D shows placement of the hinge region 58 interior to the balloon44. The balloon 44 extends between the guidewire/delivery tube 56 andthe outer catheter tube 40 enclosing the annular inflation lumen 42. Thepush-pull wire 62 is attached to the distal end 65 of theguidewire/delivery lumen tube 56. In each of the variations shown inFIGS. 2A to 2D, the push-pull wire 62 may be attached at its distal endto the catheter through a variety of methods, e.g., adhesives, crimping,mechanical fasteners, etc. In this variation, a radio-opaque marker band67 may be used to anchor the wire 62. Moreover, other attachment sitesfor attachment of the push-pull wire 62 distal to the hinge region 58will be apparent. The push-pull wire itself is preferably a wire whichhas sufficiently high column and tensile strengths such that it may bepushed or pulled along a longitudinal axis of the wire through the wirelumen without buckling or kinking. It may be fabricated into a wirehaving a circular cross-section, although other cross-sectional shapesmay be utilized, having a diameter, for instance, ranging from 0.025 mmand higher. The push-pull wire may be fabricated from a biocompatiblemetallic material such as stainless steel, platinum, etc. Alternatively,the push-pull wire 62 may also include a tapered wire which has a largerdiameter at or near its proximal end and a smaller diameter at or nearits distal end. Conventional guidewires may also be utilized as apush-pull wire, provided that it has an adequate diameter and sufficientcolumn and tensile strengths desirable for manipulating the flexibledistal end of the device.

In FIG. 2D, extension of the delivery lumen tube 56 beyond the end ofthe inflation lumen 42 allows remote manipulation of the catheter'sdistal end 65 if the push-pull wire 62 is attached to the catheterusing, e.g., markers or platinum bands 67. The delivery tube lumen 56may be made of any of the above materials with respect to tube 26 inFIG. 1.

Some of the various configurations of the catheter's lumina (inflation,push-pull, delivery, etc.) are displayed in FIGS. 3A through 3H. In FIG.3A, the optional inflation lumen 122 and push-pull wire lumen 124 areformed interior to the catheter wall 120, while the interior catheterwall forms the guidewire lumen 128. In FIG. 3B, the catheter wall 120forms the guidewire lumen 128 which contains the optional inflationlumen 122 and push-pull wire lumen 124. The optional inflation lumen 122is formed interior to the catheter wall 120 of FIG. 3C, while thepush-pull wire lumen 124 lies within the larger coil lumen 128 (which isformed by the catheter wall 120).

FIG. 3D is a variation of FIG. 3C in which the push-pull wire lumen 124lies interior to the catheter wall 128 while the optional inflationlumen 122 lies within the larger main lumen 128. In FIG. 3E, theinterior catheter wall 120 forms the optional inflation lumen 122, andthe push-pull wire lumen 124 and the main lumen 128 are found within theinflation lumen 122. The optional inflation lumen 122 surrounds theguidewire lumen 128 and lies within the region formed interior catheterwall 120 in FIG. 3F, while the push-pull wire lumen 124 lies within thecatheter wall 120. In FIG. 3G, one shared lumen 123 serves as thepush-pull and optional inflation lumen; the shared push-pull andinflation lumen 123 along with the guidewire lumen 128 lie within thecatheter wall 120. Another alternate variation of the luminapositioning, shown in FIG. 3H, has the push-pull wire lumen 124 lyinginterior to the inflation lumen 122 which is contained within thecatheter wall 120, while a separate lumina for the guidewire 128 also iscontained within the catheter wall.

The tube constructions, hinge region construction, and other tubingforming the various lumina discussed herein may be created throughextrusion, sequential production (in which the parts are manufacturedseparately and later assembled together), or some other method known toone of skill in the art. Moreover, if use of the balloon is omitted fromthe catheter assembly, the inflation lumen may be omitted entirely aswell.

FIG. 4A shows a cross-sectional side view of another variation of acatheter assembly 210. This particular variation may have a catheterbody 212 with a main lumen 216 defined through the length of theassembly 210. The push-pull wire lumen 214 may also be defined throughthe length of the catheter body 212, or at least through a majority ofthe length of catheter body 212, extending from a fitting 232 at aproximal end of the catheter assembly 210 to a region near or at thedistal end of the device. The catheter body 212 itself may be comprisedof several regions, each having a different degree of flexibility. Forinstance, the catheter assembly 210 may comprise a first portion 220distal of the fitting 232 having a first stiffness. A second portion222, having a second stiffness and located distal of the first portion220, may be more flexible relative to the first portion 220. Likewise, athird portion 224, having a third stiffness and located distal of thesecond portion 222, may be more flexible relative to the first andsecond portions 220, 222, respectively. Thus, the catheter body 212 mayhave a length comprised of progressively more flexible sections that arefarther distally located along the catheter 212. Bending portion orflexible joint region 218 may be positioned distal to the third section224, as described in further detail below.

The push-pull wire lumen 214 is preferably reinforced along at least asubstantial portion of its length. The wire lumen 214 may include abraided ribbon 236 integrated throughout the length of lumen 214 alongcatheter body length 226. Alternatively, the braided ribbon 236 may beintegrated through lumen 214 to terminate proximally of joint region218, as shown in the FIG. 4A. The braided ribbon 236 may be a uniformbraid or it may be braided with a varying braid pitch. For instance,proximal sections of the catheter body 212, such as first portion 220,may have a braid which is tighter or which has a higher braid pitch thanmore distally located sections, such as third portion 224. If a regionof lower braid pitch is flanked by regions of higher braid pitch, theregion of greater pitch may generally be stiffer during manipulation ofthe distal catheter tip.

The braided ribbon 236 may be made from a number of materials. Forinstance, metals which are members of a class of alloys know assuper-elastic alloys may be utilized for the braid material. Preferredsuper-elastic alloys include the class of nickel-titanium materialstypically known as Nitinol. Other appropriate metals may also beutilized, such as stainless steel or polymers may also be used such asliquid crystal polymers (LCP's). The braids which may be utilized inthis invention are preferably made using commercially available tubularbraiders. The term “braid” may generally include tubular constructionsin which the ribbons making up the construction may be woven radially inan in-and-out fashion as they cross to form a tubular member defining asingle lumen. Other braiding variations may also be utilized astypically known in the art. The braid may also be made from a suitablenumber of ribbons or wires. FIG. 4D shows a cross-section of catheterbody 212. As shown, wire lumen 214 may have a liner 246, e.g., alubricious polymeric liner, such as polytetrafluoroethylene (PTFE),available commercially under the trade name “TEFLON,” for example,disposed upon the lumen wall to facilitate movement of the push-pullwire therethrough. The liner 246 may be made from any variety ofsuitable polymeric materials as mentioned above. Alternatively, thebraided ribbon 236 may be positioned upon the inner surface of wirelumen 214. In such a configuration, a lubricious coating may beoptionally omitted from the distally located portions of the device.

Although three sections of variable stiffness are described in thisvariation, this is intended to be illustrative. Catheters having as fewas two sections or multiple (i.e., greater than three) sections ofvariable stiffness are also contemplated to be within the scope of theinvention. Furthermore, although it is preferable to have the sectionswith decreasing stiffness (or greater flexibility) the further distallyalong the catheter body 212, other variations may include distallylocated sections with increasing stiffness or alternating sections ofrelatively stiffer and more flexible sections, or any othercombinations.

First portion 220 may, for example in one variation, have a typicallength of about 100 cm (±1 cm) with a stiffness or relative durometerhardness value of 72 D. The second portion 222 may have a length ofabout 30 cm (±1 cm) with a lower stiffness or hardness of 63 D. Thirdportion 224 may likewise have a length of about 30 cm (±1 cm) with aneven lower stiffness or hardness value of 40 D. In either case, the mainlumen 216 may be defined by a tubing having a stiffness or relativehardness of, e.g., 63 D, encased throughout the length of the device.Each of the sections are preferably integral with adjacent sections. Thevariable stiffness may be effected through one of any variety of methodsgenerally known in the art, e.g., different sheaths or coverings havingdiffering stiffness. For instance, PEBAX (Atochem Corporation of France)or any other polymeric material mentioned above, having the variablestiffness may be utilized to cover the respective sections.

The manipulatable or flexible joint region 218 is generally located atthe distal end of the catheter body 212 and is configured to bend whenmanipulated by the push-pull wire. Flexible joint region 218 may beconfigured to have a length ranging from, e.g., 3 mm to 3 cm. Asmentioned above, the braided ribbon 236 may terminate proximally of theflexible joint region 218. The bending portion 218 itself may be variedto extend to where braid 236 terminates, or it may be extended tobending portion 228 to encompass a portion of the braid 236. Theflexible joint region 218 may be covered by PEBAX, or any otherpolymeric material mentioned above, having a stiffness or hardness of,e.g., 25 D, which is lower than a stiffness of third portion 224.

As mentioned above, the proximal portion of the catheter body 212 may beattached to fitting 232. Fitting 232 may be any variety of fittingtypically utilized with intra-luminal catheters. In this variation,fitting 232 may define an opening 234 which is in communication withmain lumen 216 to allow for the passage of guidewires, various tools,therapeutic drugs, etc. It may also be configured to accept a separatelymanufactured push-pull wire handle 238 with a control 240 formanipulating the push-pull wire distally or proximally along alongitudinal axis of the wire. Alternatively, the push-pull wire handle238 may be formed as an integrated piece with fitting 232. Although thefigure shows the inclusion of opening 234 in the proximal end of fitting232, other variations may include rapid-exchange (RX) type catheterdesigns having guidewire lumen openings defined along the body ofcatheter body 212 itself.

The distal end of flexible joint region 218 may have a portion of thetubing defining the main lumen 216 extending as an extension 230 pastdistal face 242 of joint region 218, as shown in the detail side view ofFIG. 4B. The length of extension 230 may be configured to extend atvarious lengths from a relatively short length to a relatively longerlength, depending upon the desired bending results. Extension 230 mayhave a relative stiffness or hardness value, e.g., 63 D, which is higherthan the stiffness or hardness of the section located proximally, i.e.,flexible joint region 218. Moreover, an additional coating may bedisposed over extension 230 and any marker bands or wires positionedthereon to encase the assembly, as described in further detail below. Anend view of flexible joint region 218 is shown in FIG. 4C, whichillustrates the variation of push-pull wire lumen 214 formed adjacentlyto main lumen 216. As shown, main lumen 216 may have a lubricious liner244, such as polytetrafluoroethylene (PTFE), available commerciallyunder the trade name “TEFLON,” for example, defined upon an innersurface of main lumen 216 to facilitate the insertion or removal ofguidewires and/or other tools through the main lumen 216. Liner 244 maybe formed from any variety of suitable polymeric materials, as describedabove.

Returning to FIG. 4B, tubing extension 230 may extend for a shortdistance past distal face 242, for instance, about 0.15 cm. As shown inthe side view of distal portion 250 in FIG. 5A, a radio-opaque markerband 262, as mentioned above, may be attached over and/or onto extension230. The push-pull wire 258 positioned within wire lumen 214 may extendthrough an opening in distal face 242 and attach to marker band 262.Push-pull wire 258 may be attached by being routed between band 262 andextension 230 and bent around 260 marker band 262. Alternatively,additional marker bands may be positioned upon extension 230 and used tosandwich the push-pull wire 258 between the respective marker bands.Other variations for attaching the wire 258 to the marker band 262 mayalso be utilized as generally known in the art. The portion of extension230 past marker band 262 may be left or it may alternatively be trimmedflush against the marker band 262. An additional marker band may bepositioned about the push-pull wire lumen 214 to aid in positionalorientation of the catheter under an imaging system, such as afluoroscope.

The flexible joint region 218 may flex beginning where braiding 236terminates 254. Flexible joint region 218 may also incorporate anoptional transitional joint region 252 between the flexible joint region218 and the remainder of the catheter body. This transition region 252may have an intermediate flexibility between that of joint region 218and the catheter body or it may be configured to be more flexible thaneither region to facilitate bending of the region. Flexibility may beimparted to region 252, at least in part, by omitting any liners orcoatings from the main lumen 216 and/or the wire lumen 214 along theregion 252. In either case, the transition region 252 may be omittedentirely. The covering or sheath 256, which is preferably hydrophilicand may be disposed over the entire device or portions of the device,may also be omitted from the flexible joint region 218. This covering256 may also be included or omitted entirely from the transitional jointregion 252, depending upon the desired results. Optionally, the distalportion of the device (optionally including the joint region 252),perhaps 35 to 50 cm, may be covered with the hydrophilic coating, againdepending upon the desired results.

By varying the length of flexible joint region 218, the amount ofcurvature and flexure of the joint region 218 can be controlled. Forinstance, a joint region having a relatively shortened length betweenthe distal end of the joint region 218 and the terminal end 264 of thebraid, as shown in FIG. 5B, may allow for a reduced degree of flexure266 relative to a neutral position of the catheter. In comparison, asshown in FIG. 5C, a lengthened joint region extending to a moreproximally located terminal end 264′ may allow for a relatively greaterdegree of flexure 266′ relative to the flexure shown by the catheter inFIG. 5B. Accordingly, the degree of flexure may be controlled in part bythe length of the flexible joint region. Thus, the flexible region maybe flexed up to 90° relative to the longitudinal axis of the catheterassembly and in some cases, the flexible region may be flexed up to 180°relative to the longitudinal axis depending upon the length of theflexible joint region. To further facilitate bending of the catheter,additional members such as coils may be incorporated into the device,for instance in the transitional region, to aid in further controllingthe bending of the joint region.

As mentioned above, the distal flexible joint region 218 may have acoating or liner 267, preferably one that is hydrophilic for ease of usewithin a body, disposed over it and over extension 230 to encase theassembly, as shown in the cross-sectional side view of FIG. 6A. In thisvariation, marker band 262 may be disposed over the extension 230 and asecond marker band 269 may be disposed thereupon with the push-pull wire258 locked in between. In this variation, second marker band 269 islarger in diameter as well as length than marker band 262; however,other sizes and configurations known to one of skill in the art may beutilized. The liner 267, which may be fused down over the entire lengthof the joint region 218 or just a portion of the region 218, may be madeof any variety of materials described herein. The marker bands 262, 269may be utilized to facilitate visualization of a position of the distalend of the device. Optionally, a third marker band 268 may be positionedalong the device proximal to the joint region 218 to aid in visualizingpotential coiling of the device.

In order to control the advancement or retraction of the push-pull wire,which controls the flexure of the flexible joint region, a variety ofcontrols may be utilized. FIGS. 7A to 7C show side, end, and partiallyremoved side views, respectively, of one variation of a control handle.A push-pull wire guide 270 may extend from handle 238 for transitioningthe push-pull wire to the catheter. As shown in the side view of FIG.7C, which shows handle 238 partially removed for clarity, wire control240 is configured as a wheel which further defines a concentricallyconfigured gear 272, as shown in FIG. 7D, which may engage with theengagement teeth 276 of rack 274, as shown in FIG. 7E. The push-pullwire may be attached to the rack 274 so that as control 240 is rotated,rack 274 may be advanced proximally or distally to thereby translate theattached push-pull wire along the longitudinal axis of the wire.

FIG. 8 shows another variation in the cross-sectional side view ofcombination fitting/handle assembly 280. Handle body 282 may incorporatethe push-pull handle portion 284 as an integrated part of a fitting. Theassembly 280 may include a main lumen access 286 as well as a push-pullwire access 288. FIG. 8 shows a cross-sectional side view of anothervariation in handle body 290. In this variation, a carriage screw 292may be positioned within the handle 290 such that a wire carriage 294 isconfigured to travel within advancement channel 296 defined withinhandle 290. A proximal end of carriage screw 292 may be attached to acontrol knob 298, which may be rotated to advance either proximally ordistally the carriage 294 and the push-pull wire, which may be attachedto carriage 294 at push-pull wire attachment 300.

In yet another variation in FIG. 10, handle body 310 may incorporate acontrol/release knob 312 which is attached to a release screw 314. Thescrew 314 may be attached to a wire carriage 316, which may attach topush-pull wire via attachment 318. As the knob 312 is translatedproximally or distally, carriage 316 may travel within channel 320 toeither advance or retract the attached push-pull wire. Knob 312 may betightened about screw 314 against handle 310 to lock a position of thepush-pull wire during flexure, if desired. In yet another variation inFIG. 11, handle body 330 may have a control slide 332 configured toproximally or distally advance a wire carriage 334 within handle 330.

FIGS. 12 and 13 illustrate another variation of a catheter assembly 340,having a catheter body 342 with a main lumen 346 defined through thelength of the catheter assembly. The push-pull wire lumen 344 may alsobe defined through the length of the catheter body, or at least througha majority of the length of catheter body, extending from a fitting (notshown) at a proximal end of the catheter assembly to a region near or atthe distal end of the device. The catheter body itself may be comprisedof several regions, each having a different degree of flexibility.Bending portion or flexible joint region 348 may be positioned at adistal section 350 of the catheter assembly.

The push-pull wire lumen is preferably reinforced along at least asubstantial portion of its length, and, as described above, may includea braided ribbon 352 integrated throughout the length of push-pull wirelumen along catheter body length, to terminate proximally of theflexible joint region. The push-pull wire lumen may have a liner 354,e.g., a lubricious polymeric liner, disposed upon the lumen wall tofacilitate movement of the push-pull wire 356 therethrough. Thelubricious polymeric liner may be formed of a material with a lowcoefficient of friction, such as polytetrafluoroethylene (PTFE), forexample, available commercially under the trade name “TEFLON,” althoughother similar materials with a low coefficient of friction, such aspolyethylene or polypropylene, for example, may also be suitable, andthe liner may be made from any variety of suitable polymeric materialssuch as are mentioned above. The main lumen may also have such alubricious liner 357. The push-pull wire is preferably a tapered wirewhich has a larger diameter portion 358 along a proximal portion and asmaller diameter distal portion 360 at or near its distal end 362, andmay be fabricated from a biocompatible metallic material such asstainless steel, platinum, and the like. A coil 364 is placed around thesmaller diameter portion, typically approximately 6 cm at the end of an8 cm long catheter, so that the tip of the push-pull wire does notdeflect and rupture the otherwise constant diameter catheter. The coilhas the effect of distributing stress along the smaller diameter portionof the push-pull wire to prevent buckling of the smaller diameterportion of the push-pull wire. The push-pull wire is also preferablycoated with a material 366 with a low coefficient of friction, such aspolytetrafluoroethylene, for example, available commercially under thetrade name “TEFLON,” although other similar materials with a lowcoefficient of friction, such as polyethylene or polypropylene, forexample, may also be suitable.

A radio-opaque marker band 368, as mentioned above, may be attached overand/or onto the catheter body at or near the distal section of thecatheter assembly. The push-pull wire positioned within the push-pullwire lumen may attach to the marker band, such as by welding the distalend of the push-pull wire to a radially inner surface 370 of the markerband, for example, although the push-pull wire may be attached at itsdistal end to the catheter through a variety of methods, e.g.,adhesives, crimping, mechanical fasteners, and the like. An additionalmarker band may be positioned about the push-pull wire lumen to aid inpositional orientation of the catheter under an imaging system, such asa fluoroscope.

In another variation shown in FIG. 14, a strapping coil 372 may also beplaced around the outside of the catheter to prevent the catheter fromrupturing if the push-pull wire buckles when the push-pull wire ispushed. The strapping coil may be covered by an outer covering 374formed of a polymeric material, such as of PEBAX, for example, as ismentioned above. In another variation illustrated in FIGS. 15 and 16, anouter covering 376 of a very fine mesh formed of a polymeric material,such as polyethylene terephthalate (PET), for example, may be placedover the distal tip of the catheter to prevent rupture of the lumen andreinforce the push-pull wire.

The applications of the inventive catheter discussed above are notlimited to certain treatments, but may include any number of vascularmaladies. Modification of the above-described methods for carrying outthe invention, and variations of the mechanical aspects of the inventionthat are obvious to those of skill in the mechanical and guide wireand/or catheter arts are intended to be within the scope of the claims.Moreover, various combinations of aspects between examples is alsocontemplated and are considered to be within the scope of thisdisclosure.

The invention claimed is:
 1. A catheter section comprising: a catheterbody having a proximal end and a distal end, said catheter bodyincluding a distal flexible joint region, a main lumen extending throughsaid catheter body and through said flexible joint region, and a wirelumen adjacent to said main lumen and extending through said catheterbody and through said flexible joint region, the wire lumen of saidflexible joint region having an opening near or at a distal end of theflexible joint region; a push-pull wire disposed in said wire lumen,said push-pull wire being configured to be pushed distally and pulledproximally along a longitudinal axis of the wire through the wire lumen,the distal end of said push-pull wire attached to said distal flexiblejoint region such that translation of said push-pull wire distally orproximally effects flexion of said distal flexible joint region of saidcatheter, the push-pull wire having a proximal portion of a firstdiameter and a distal portion of a smaller diameter than said firstdiameter, and the wire lumen including a lubricious lining along atleast a substantial portion of the wire lumen; a coil disposed in saidwire lumen around the smaller diameter distal portion of said push-pullwire, said coil being wound in close contact with said smaller diameterdistal portion of said push-pull wire and configured to limit lateraldeflection of the smaller diameter distal portion of said push-pull wiresufficient to prevent rupture of said wire lumen and said catheter bodyby said smaller diameter distal portion of said push-pull wire when saidpush-pull wire is pushed distally, and a coating of a material with alow coefficient of friction disposed over the push-pull wire; and acontrol in communication with a proximal end of the push-pull wire, saidcontrol being configured to push said push-pull wire distally and pullsaid push-pull wire proximally to control flexion of the flexible jointregion.
 2. The catheter section of claim 1, further comprising astrapping coil disposed around the outside of the catheter, saidstrapping coil being configured to prevent said catheter body fromrupturing when said push-pull wire is pushed.
 3. The catheter section ofclaim 2, further comprising an outer covering formed of a polymericmaterial disposed around the strapping coil.
 4. The catheter section ofclaim 3, wherein the outer covering disposed around the strapping coilis formed of PEBAX.
 5. The catheter section of claim 1, furthercomprising an outer covering of a mesh formed of a polymeric materialdisposed around the distal tip of the catheter, said mesh beingconfigured to prevent said catheter body from rupturing when saidpush-pull wire is pushed.
 6. The catheter section of claim 5, whereinthe mesh is formed of polyethylene terephthalate.
 7. The cathetersection of claim 1, further comprising at least one radio-opaque bandnear or at the distal end of the flexible joint region.
 8. The cathetersection of claim 1, wherein the wire lumen further comprises a braidalong at least a substantial portion of the wire lumen.
 9. The cathetersection of claim 8, wherein the braid terminates proximally of theflexible joint region.
 10. The catheter section of claim 1, wherein themain lumen further comprises a lining along at least a substantialportion of the main lumen.
 11. The catheter section of claim 10, whereinthe lining comprises a lubricious lining.
 12. The catheter section ofclaim 7, wherein said push-pull wire extends through said opening ofsaid wire lumen at said distal end of said flexible joint region, and isattached to said marker band.